Phase 4
Completed N=265
Telemedicine Outreach for Post Traumatic Stress in CBOCs
Source: ClinicalTrials.gov NCT00821678 ↗Enrolled (actual)
265
Serious AEs
1.9%
Results posted
Apr 2015
Primary outcomePrimary: Change in PTSD Symptom Severity (PDS) — -5.31; -1.07 units on a scale — p=0.002
Summary
The purpose of this study is improved outcomes for veterans with Post Traumatic Stress Disorder (PTSD) treated in small VA Community Based Outpatient Clinics (CBOCs). Although psychotherapy and pharmacotherapy treatments for PTSD have been proven to be efficacious in controlled trials, geographic barriers often prevent veterans from accessing these evidence-based treatments. Telemedicine technologies will be used to overcome geographic barriers to care. Specifically, we will evaluate the Telemedicine Outreach for PTSD (TOP) intervention which is based on the principals of the Chronic Care Model and Disease Management, and builds on the evidence base of quality improvement for depression in primary care settings. The TOP intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records) to treat CBOC patients with a newly emerging or chronic PTSD. We hypothesize that study participants randomized to the TOP intervention will receive higher quality of care and experience better outcomes compared to study participants randomized to treatment as usual.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Symptom Severity (PDS) |
-5.31; -1.07 | 0.002 sig |
| SECONDARY Change in Continuous Measure of Depression Symptom Severity (SCL-20) |
-0.43; -0.16 | 0.001 sig |
| SECONDARY Change in Continuous Measure of Alcohol Use (Audit Score) |
-0.36; -0.17 | 0.48 |
| SECONDARY Change in Continuous Measure of Health Status (SF12V PCS) |
0.77; -1.45 | 0.02 sig |
| SECONDARY Change in Continuous Measure of Quality of Life (QWB) |
-0.00407; -0.00800 | — |
| SECONDARY Satisfaction With Care (ECHO) |
8.83423; 7.7043 | — |
| SECONDARY Medication Adherence, Defined as Taking Medication <80% of Days |
62; 68 | 0.65 |
| SECONDARY Received at Least 8 Sessions of Exposure Based Therapy |
36; 7 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- diagnostic Criteria for PTSD (CAPS),
- veterans,
- treated in CBOC
Exclusion Criteria
- schizophrenia,
- bipolar disorder,
- current substance dependence,
- current specialty PTSD treatment at VA Medical Center,
- no access to telephone,
- hearing or speech impediment,
- terminal illness,
- non-capacity to consent
Data sourced from ClinicalTrials.gov (NCT00821678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.